The Decline of Pharmaceutical Innovation in Europe
The first keynote speaker Georgette Lalis, Head of DG Enterprise and Industry for the European Commission, began her presentation "The Decline of Pharmaceutical Innovation in Europe" by acknowledging, "Innovation is the life blood of the pharmaceutical industry." She added that regulators must be equally innovative, playing a key role in the growth of R&D development in Europe, noting that Europe is facing massive health threats and the health system is under distress.
The first keynote speaker Georgette Lalis, Head of DG Enterprise and Industry for the European Commission, began her presentation "The Decline of Pharmaceutical Innovation in Europe" by acknowledging, "Innovation is the life blood of the pharmaceutical industry." She added that regulators must be equally innovative and play a key role in the growth of R&D development in Europe, noting that Europe is facing massive health threats and has a health system that is under distress.
Lalis suggested that Europe needs to inject a new impetus and not increase barriers-this will help develop a firm foundation for innovation. And although a great deal has been achieved (such as successful orphan regulation, an increase in the number of new medicines and pediatric medications, and developing legislation for tissue engineering and cell therapy), what has been done so far is still not enough. Lalis added that the Commission will propose a series of measures to remove bureaucratic hurdles and that there needs to be a refocus on non-legislative areas, such as improving information to patients, assessing cost effectiveness of drugs, and looking for alternative approaches to pricing. "Innovation is not new to Europe," she concluded.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
